PregnancyAGpNCT03002987
Active Pregnancy Policy at Work. Greater Wellbeing and Lower Sickness Absence
A study testing Active Pregnancy policy in people with Pregnancy and Sickness Absence, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
In a cluster randomized design it will be investigated whether teaching local leaders how to implement active pregnancy policy results in less sickness absence among their pregnant employees. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Sickness Absence, Occupational Exposure
- What is being tested?
- Active Pregnancy policy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 866 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2017to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- pregnancy during intervention period, employed at one of the included departments/workplaces
Who cannot join
- not being able to understand, write and read Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of occupational and evironmental medicine
Copenhagen, 2400
About this study
In a cluster randomized design it will be investigated whether teaching local leaders how to implement active pregnancy policy results in less sickness absence among their pregnant employees. Further it will be investigated to what extent Active pregnancy policy is implemented at the departments and whether it results in higher sense of security and wellbeing among the pregnant employee. Finally the cost and benefits of the intervention will be analyzed.
Read the detailed description
Background: The majority of Danish women work during their reproductive years. Sickness absence among pregnant women is frequent; more than one third of Danish women are on longterm sick leave during pregnancy. Sick leave has been found associated with occupational exposures and studies have shown that adjustment in exposure can reduce sick leave in pregnancy indicating that there are potential preventive initiatives.
Design and outcomes: In a cluster randomized design it will be investigated whether teaching local leaders how to implement active pregnancy policy results in less sickness absence among their pregnant employees. It will further be investigated to what extent Active pregnancy policy is implemented at the departments and whether it results in higher sense of security and wellbeing among the pregnant employee. Finally the cost and benefits of the intervention will be analyzed.
The study takes place at hospitals in the two regions on Zealand, Denmark (The Capital region of Denmark and Region Zealand) and in the daycare sector in 2 municipalities located in The Capital region of Denmark. The randomization will be at the level of departments, which will be randomized to either intervention or control:
Intervention: The leaders are invited to a 3 hours seminar, where they will be taught in how to implement active pregnancy policy at their department.
Control: as usual
All employees at the involved departments getting pregnant during the year of intervention will be included in the study. They are to answer a questionnaire at 28th week of gestation and their days of sick leave during pregnancy will be recorded. All leaders at the departments are to answer two questionnaires, one before randomization and one after intervention.
The intervention: At the 3 hours seminar the leaders will receive education containing: 1) Updates on evidence on pregnancy and risk of occupational exposures, 2) information about the rules in the area and the leader's responsibilities, 3) Answers and solutions to frequent issues relating pregnant employees at work and 4) Introduction to Active Pregnancy policy.
The content of Active Pregnancy Policy: A congratulation letter to the pregnant employee inviting her to a meeting. At the meeting her job task will be discussed and fears and worries taken hand on. The aim is to adjust the job tasks to the employee and her special need during her pregnancy. During the pregnancy the leader regularly evaluate with the pregnant employee on how it goes and if there are needs for other or further adjustments. A minimum of 3 planned meetings have to be held during the pregnancy. Further the leader shall inform the other employees at the workplace about the arrangements made with the pregnant employee.
- Conditions
- Pregnancy, Sickness Absence, Occupational Exposure
- Being tested
- Active Pregnancy policy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Pregnancy policyBehavioural
Education (3 hours) of leaders in how to implement Active pregnancy policy at their departments/work places
| Study group | Role | What they receive |
|---|---|---|
| Intervention, education | Active comparator | Education of leaders (3 hours) in how to implement Active Pregnancy policy at their departements/workplaces Receives: Behavioral: Active Pregnancy policy |
| control | No intervention | as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy related sick leave
difference in pregnancy related sick leave between the two randomized groups. In days and the proportion of pregnant employee with longterm sick leave (> 4 weeks)
Measured: one year (intervention period)
Secondary outcomes (3)
To what extent Active pregnancy policy is implemented at the departments/workplaces
Difference between the two randomized groups in relation to the proportion of pregnant employees who experienced active pregnancy policy (different parts: Received congratulation letter, had scheduled meetings discussing the possible occupational exposures, adjustment of work tasks)
Measured: one year (intervention period)
Wether active pregnancy policy lead to higher sense of security and wellbeing among the pregnant employees
Difference between the two randomized groups in relation to the experience of security and wellbeing among the pregnant employees. Using the WHO-5 and variables concerning the psychosocial work environment
Measured: one year
cost effectiveness of the intervention
calculating the costs of the intervention: 1)Holding the seminars (place, salary for teachers, food supply etc.) 2) time used (the leaders salary) attending the seminars, 3) Teaching material and the cost of resources used at the departments (control vs. intervention): 1) time used hiring temporary employees, 2) time used talking with pregnant employees, 3) time used changing the work tasks of the pregnant employee, 4) Salary to hired temporary employees.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start1 Sep 2017
- Primary completion1 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 866 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luise Mølenberg Begtrup, Bispebjerg Hospital
- Investigators
- Luise Moelenberg Begtrup, MD, Principal investigator, Department of occupational Medicine, Bipspebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002987
- Sponsor's protocol ID
- AGp2016
- Acronym
- AGp
- Status last verified
- Apr 2020
- First submitted
- 19 Dec 2016
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Begtrup LM, Malmros P, Brauer C, Soegaard Toettenborg S, Flachs EM, Hammer PEC, Bonde JP. Manager-oriented intervention to reduce absence among pregnant employees in the healthcare and daycare sector: a cluster randomised trial. Occup Environ Med. 2021 Jun 14;78(7):486-493. doi: 10.1136/oemed-2020-106794.
PubMed 33436380
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Pregnancy Policy at Work. Greater Wellbeing and Lower Sickness Absence
- ClinicalTrials.gov ID
- NCT03002987
- Acronym / sponsor ID
- AGp / AGp2016
- Conditions
- Pregnancy, Sickness Absence, Occupational Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 866 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 26 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a cluster randomized design it will be investigated whether teaching local leaders how to implement active pregnancy policy results in less sickness absence among their pregnant employees. Further it will be investigated to what extent Active pregnancy policy is implemented at the departments and whether it results in higher sense of security and wellbeing among the pregnant employee. Finally the cost and benefits of the intervention will be analyzed.
Detailed description
Background: The majority of Danish women work during their reproductive years. Sickness absence among pregnant women is frequent; more than one third of Danish women are on longterm sick leave during pregnancy. Sick leave has been found associated with occupational exposures and studies have shown that adjustment in exposure can reduce sick leave in pregnancy indicating that there are potential preventive initiatives.
Design and outcomes: In a cluster randomized design it will be investigated whether teaching local leaders how to implement active pregnancy policy results in less sickness absence among their pregnant employees. It will further be investigated to what extent Active pregnancy policy is implemented at the departments and whether it results in higher sense of security and wellbeing among the pregnant employee. Finally the cost and benefits of the intervention will be analyzed.
The study takes place at hospitals in the two regions on Zealand, Denmark (The Capital region of Denmark and Region Zealand) and in the daycare sector in 2 municipalities located in The Capital region of Denmark. The randomization will be at the level of departments, which will be randomized to either intervention or control:
Intervention: The leaders are invited to a 3 hours seminar, where they will be taught in how to implement active pregnancy policy at their department.
Control: as usual
All employees at the involved departments getting pregnant during the year of intervention will be included in the study. They are to answer a questionnaire at 28th week of gestation and their days of sick leave during pregnancy will be recorded. All leaders at the departments are to answer two questionnaires, one before randomization and one after intervention.
The intervention: At the 3 hours seminar the leaders will receive education containing: 1) Updates on evidence on pregnancy and risk of occupational exposures, 2) information about the rules in the area and the leader's responsibilities, 3) Answers and solutions to frequent issues relating pregnant employees at work and 4) Introduction to Active Pregnancy policy.
The content of Active Pregnancy Policy: A congratulation letter to the pregnant employee inviting her to a meeting. At the meeting her job task will be discussed and fears and worries taken hand on. The aim is to adjust the job tasks to the employee and her special need during her pregnancy. During the pregnancy the leader regularly evaluate with the pregnant employee on how it goes and if there are needs for other or further adjustments. A minimum of 3 planned meetings have to be held during the pregnancy. Further the leader shall inform the other employees at the workplace about the arrangements made with the pregnant employee.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention, education | Active comparator | Behavioral: Active Pregnancy policyEducation of leaders (3 hours) in how to implement Active Pregnancy policy at their departements/workplaces |
| control | No intervention | –as usual |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- pregnancy during intervention period, employed at one of the included departments/workplaces
Key exclusion criteria (1 listed)
- not being able to understand, write and read Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Pregnancy policyEducation (3 hours) of leaders in how to implement Active pregnancy policy at their departments/work places | Behavioural | Intervention, education |
Primary outcome
pregnancy related sick leave
Time frame: one year (intervention period)
difference in pregnancy related sick leave between the two randomized groups. In days and the proportion of pregnant employee with longterm sick leave (> 4 weeks)
3 secondary outcomes
To what extent Active pregnancy policy is implemented at the departments/workplaces
Time frame: one year (intervention period)
Wether active pregnancy policy lead to higher sense of security and wellbeing among the pregnant employees
Time frame: one year
cost effectiveness of the intervention
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 33436380Begtrup LM, Malmros P, Brauer C, Soegaard Toettenborg S, Flachs EM, Hammer PEC, Bonde JP. Manager-oriented intervention to reduce absence among pregnant employees in the healthcare and daycare sector: a cluster randomised trial. Occup Environ Med. 2021 Jun 14;78(7):486-493. doi: 10.1136/oemed-2020-106794.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luise Moelenberg Begtrup, MD principal investigator
Department of occupational Medicine, Bipspebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Pregnancy policy in people with Pregnancy and Sickness Absence, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy related sick leave (time frame: one year (intervention period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03002987, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.